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Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure. (DREAM HF-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02032004
Recruitment Status : Active, not recruiting
First Posted : January 9, 2014
Last Update Posted : April 5, 2019
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast, Inc. )

Brief Summary:
The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Biological: Allogeneic Mesenchymal Precursor Cells (MPC) Other: Sham Comparator Phase 3

Detailed Description:
The purpose of this study is to evaluate the efficacy and safety of a single transendocardial delivery in the cardiac catheterization laboratory of human bone marrow-derived allogeneic MPCs (rexlemestrocel-L) for improvement in clinical outcomes (HF-MACE), preventing further adverse cardiac remodeling (LVESV and LVEDV), and increasing exercise capacity (6MWT) in patients with chronic HF due to LV systolic dysfunction of either ischemic or nonischemic etiology who have received optimal medical/revascularization therapy.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 566 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Sham-procedure-controlled, Parallel-Group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) in Chronic Heart Failure Due to LV Systolic Dysfunction (Ischemic or Nonischemic) Dream HF-1
Actual Study Start Date : January 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Allogeneic Mesenchymal Precursor Cells
Participants randomly assigned to treatment will undergo a single index cardiac catheterization involving transendocardial delivery of rexlemestrocel-L into the myocardium at a cell injection center by an interventional cardiology team not involved with review or assessment of subsequent study results.
Biological: Allogeneic Mesenchymal Precursor Cells (MPC)
Rexlemestrocel-L consists of human bone marrow-derived allogeneic MPCs isolated from bone mononuclear cells with anti-STRO-3 antibodies, expanded ex vivo,and cryopreserved
Other Names:
  • MPC
  • rexlemestrocel-L

Sham Comparator: Control Treatment
Participants randomly assigned to control treatment will undergo a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center by an interventional cardiology team not involved with review or assessment of subsequent study results.
Other: Sham Comparator
The sham procedure will be staged to script and will not include actual cardiac mapping or delivery of rexlemestrocel-L.




Primary Outcome Measures :
  1. Time to recurrent non-fatal decompensated heart failure major adverse cardiac events (HF-MACE) that occur prior to the first terminal cardiac event (TCE). [ Time Frame: 6 Month minimum ]

Secondary Outcome Measures :
  1. Time-to-first terminal cardiac event (TCE) [ Time Frame: 6 Month minimum ]
  2. Time-to-hospital admissions for non-fatal decompensated HF events [ Time Frame: 6 Month minimum ]
  3. Time-to-urgent care outpatient HF visits [ Time Frame: 6 Month minimum ]
  4. Time-to-successfully resuscitated cardiac death (RCD) events [ Time Frame: 6 Month minimum ]
  5. Total length of in-hospital stay in intensive care unit for non-fatal decompensated HF events [ Time Frame: 6 Month minimum ]
  6. Time-to-first HF-MACE (composite of hospital admissions for decompensated HF, urgent care outpatient HF visit, and successfully RCD events) [ Time Frame: 6 Month minimum ]
  7. Time-to-first HF-MACE (composite of hospital admissions for decompensated HF, urgent care outpatient HF visit, successfully RCD events or TCE) [ Time Frame: 6 Month minimum ]
  8. Time-to-cardiac death [ Time Frame: 6 Month minimum ]
  9. Time-to-all-cause death [ Time Frame: 6 Month minimum ]
  10. Time-to-first non-fatal MI (myocardial infarction), non-fatal CVA (cerebrovascular attack) or coronary artery revascularization [ Time Frame: 6 Month minimum ]
  11. Left Ventricular (LV) remodeling in LVESV determined by 2-D echocardiography [ Time Frame: Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
  12. Correlations between baseline LVESV <=100 mL and LVESV >100 mL and clinical outcomes [ Time Frame: 6 Month minimum ]
  13. Correlations between baseline LVESV <=100 mL and LVESV >100 mL and change in Month 6 to baseline LVESV and clinical outcomes [ Time Frame: 6 Month minimum ]
  14. LV remodeling in LVEDV determined by 2-D echocardiography [ Time Frame: Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
  15. Overall Left Ventricular systolic performance as assessed by LVEF (RVG or echocardiogram) [ Time Frame: Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
  16. Functional exercise capacity as assessed by 6 Minute Walk Test [ Time Frame: Screening, months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
  17. Functional status by New York Heart Association (NYHA) class [ Time Frame: Screening, months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
  18. Quality of Life Measure - Minnesota Living With Heart Failure (MLHF) questionnaire [ Time Frame: Screening, months 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
  19. Quality of Life Measure - EuroQoL 5-dimensional (EQ-5D) questionnaire [ Time Frame: Screening, months 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
  20. Safety as assessed by occurrence of adverse events related to the index cardiac catheterization on Day 0 [ Time Frame: Day 0 through discharge from Day 0 hospitalization ]
  21. Safety as assessed by occurrence of treatment-emergent adverse events [ Time Frame: Screening through 6 Month minimum ]
  22. Safety as assessed by clinical laboratory tests (serum chemistry - ALT, AST, alkaline phosphate, GGT, LDH, BUN, creatinine, uric acid, total bilirubin - and hematology - hematocrit, hemoglobin, WBC, eosinophils, ANC, platelet count) [ Time Frame: Screening, day 0 (post-procedure), day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
  23. Safety as assessed by urinalysis (blood, glucose, ketones, total protein) [ Time Frame: Screening, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
  24. Safety as assessed by vital signs (pulse, systolic BP, diastolic BP) [ Time Frame: Screening, day 0 (pre and post-procedure), day 1, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
  25. Safety as assessed by 12-lead electrocardiogram (ECG) findings - QTcF, QTcB, QT, QRS complex, HR and T waves. [ Time Frame: Screening, day 0 (pre and post-procedure), day 1, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
  26. Safety as assessed by telemetry monitoring findings (clinically significant arrhythmias) [ Time Frame: Day 0 through Day 0 overnight post-procedure ]
  27. Safety as assessed by rhythm analysis (specifically, ventricular arrhythmias) by interrogation of any implanted device capable of defibrillation [ Time Frame: Day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
  28. Safety as assessed by 24-hr Holter monitoring (HR, rate & duration of arrhythmias, a-fib average rate, supra- & ventricular ectopy singles/couplets/runs/totals, sustained & non-sustained ventricular tachycardia, longest pauses RR duration, total pauses) [ Time Frame: Screening, day 0 (post-procedure), day 10, months 1 and 3 ]
  29. Safety as assessed by physical examination findings judged as clinically significant changes from baseline by the investigator or newly occurring abnormalities (including weight) [ Time Frame: Screening, month 12 and every 12 months thereafter until study conclusion (weight measured at screening, day 0 - pre and post-procedure, day 1, day 10, months 1, 3, 6 and 12 and every 6 months thereafter) ]
  30. Safety as assessed by important cardiovascular events from adjudicated data [ Time Frame: 6 Month minimum ]

Other Outcome Measures:
  1. Pharmacodynamics Measures (NT-proBNP and hsCRP) [ Time Frame: Screening, months 3, 6, 12 and every 12 months thereafter until study conclusion ]
  2. Pharmacogenomics (PGx) Analysis [ Time Frame: Screening (only from those subjects who provide consent to participate in PGx sample collection) ]
  3. Immunogenicity Measures (panel reactive antibodies, donor specific antibody, if PRA test is positive, antibodies against bovine and murine products) [ Time Frame: Screening, day 10, months 1, 3, 6, and 12 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is 18 to 80 years of age, inclusive; both men and women will be enrolled.
  • The patient has a diagnosis of chronic HF of ischemic or nonischemic etiology for at least 6 months
  • The patient is on stable, optimally tolerated dosages of HF therapies including beta-blockers (approved for country-specific usage), angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), and/or aldosterone antagonists, without change in dose for at least 1 month before study intervention
  • The patient is on a stable, outpatient, oral diuretic dosing regimen in which the patient remains clinically stable during screening.
  • Other Criteria apply, please contact the investigator

Exclusion Criteria:

  • The patient has NYHA Functional Class I or Functional Class IV symptoms.
  • Other Criteria apply, please contact the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032004


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Locations
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United States, Alabama
Mesoblast Investigational Site 10757 - Cardiology, P.C.
Birmingham, Alabama, United States, 35211
Mesoblast Investigational Site 13262 - University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States, 35233
United States, Arizona
Mesoblast Investigational Site 10779 - Mercy Gilbert Medical Center
Gilbert, Arizona, United States, 85297
Mesoblast Investigational Site 10786 - Cardiovascular Associates of Mesa
Mesa, Arizona, United States, 85206
Mesoblast Investigational Site 10756 - Mayo Clinic
Phoenix, Arizona, United States, 85054
Mesoblast Investigational Site 13023 - University of Arizona Medical Center
Tucson, Arizona, United States, 85724
United States, California
Mesoblast Investigational Site 10754 - University of California, San Diego
La Jolla, California, United States, 92037
Mesoblast Investigational Site 10759 - Scripps Clinic
La Jolla, California, United States, 92037
Mesoblast Investigational Site 13265 - University of California, Los Angeles
Los Angeles, California, United States, 90045
Mesoblast Investigational Site 10775 - Cedars-Sinai Medical Care Foundation
Los Angeles, California, United States, 90211
Mesoblast Investigational Site 10778 - Orange County Cardiology
Orange, California, United States, 92868
Mesoblast Investigational Site 13031 - St. John's Regional Medical Center
Oxnard, California, United States, 93030
Mesoblast Investigational Site 13275 - Stanford University Hospital
Stanford, California, United States, 94305
United States, Florida
Mesoblast Investigational Site 13267 - Bethesda Heart Hospital
Boynton Beach, Florida, United States, 33435
Mesoblast Investigational Site 10780 - Morton Plant Hospital
Clearwater, Florida, United States, 33756
Mesoblast Investigational Site 10760 - Shands Hospital, University of Florida
Gainesville, Florida, United States, 32610
Mesoblast Investigational Site 13273 - University of Florida Health
Jacksonville, Florida, United States, 32209
Mesoblast Investigational Site 10768 - University of Miami
Miami, Florida, United States, 33215
Mesoblast Investigational Site 13280
Orlando, Florida, United States
Mesoblast Investigational Site 13264 - Florida Hospital Pepin Heart Institute
Tampa, Florida, United States, 33613
United States, Georgia
Mesoblast Investigational Site 13027 - Emory University School of Medicine
Atlanta, Georgia, United States, 30322
Mesoblast Investigational Site 10765 - Georgia Regents University
Augusta, Georgia, United States, 30912
United States, Illinois
Mesoblast Investigational Site 10772 - University Cardiologist, Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Iowa
Mesoblast Investigational Site 13030 - University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kentucky
Mesoblast Investigational Site 10783 - Gill Heart Institute, University of Kentucky
Lexington, Kentucky, United States, 40536
Mesoblast Investigational Site 13022 - University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Mesoblast Investigational Site 13266
New Orleans, Louisiana, United States
United States, Massachusetts
Mesoblast Investigational Site 10782
Boston, Massachusetts, United States
United States, Michigan
Mesoblast Investigational Site 10766 - Michigan Cardiovascular Institute
Saginaw, Michigan, United States, 48602
United States, Minnesota
Mesoblast Investigational Site 10762 - Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
Mesoblast Investigational Site 10761 - Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Nevada
Mesoblast Investigational Site 13281
Las Vegas, Nevada, United States
United States, New Jersey
Mesoblast Investigational Site 13263 - RWJ Barnabas Heart Center
Newark, New Jersey, United States, 07112
United States, New York
Mesoblast Investigational Site 10776 - Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Mesoblast Investigational Site 13026 - Sanger Heart and Vascular Institute, Carolinas Healthcare System
Charlotte, North Carolina, United States, 28203
Mesoblast Investigational Site 10781 - Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Mesoblast Investigational Site 10758 - The Christ Hospital
Cincinnati, Ohio, United States, 45219
Mesoblast Investigational Site 10770 - University of Cincinnati
Cincinnati, Ohio, United States, 45267
Mesoblast Investigational Site 10773
Cleveland, Ohio, United States
Mesoblast Investigational Site 13278 - OhioHealth Research Institute
Columbus, Ohio, United States, 43214
United States, Pennsylvania
Mesoblast Investigational Site 10785 - Lehigh Valley Hospital
Allentown, Pennsylvania, United States, 18103
Mesoblast Investigational Site 13261 - University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Mesoblast Investigational Site 10767 - Temple University Hospital
Philadelphia, Pennsylvania, United States, 19140
Mesoblast Investigational Site 13277
Philadelphia, Pennsylvania, United States
Mesoblast Investigational Site 10774 - University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Mesoblast Investigational Site 10777 - Stern Cardiovascular Foundation
Germantown, Tennessee, United States, 38125
United States, Texas
Mesoblast Investigational Site 13024 - Austin Heart, PLLC
Austin, Texas, United States, 78756
Mesoblast Investigational Site 13274 - Soltero CV Research Center, Baylor Scott & White Research Institute
Dallas, Texas, United States, 75226
Mesoblast Investigational Site 10755 - Texas Heart Institute
Houston, Texas, United States, 77030
Mesoblast Investigational Site 13268 - Houston Methodist Hospital
Houston, Texas, United States, 77030
United States, Utah
Mesoblast Investigational Site 10763 - University Hospital
Salt Lake City, Utah, United States, 84132
United States, Washington
Mesoblast Investigational Site 10771 - Heart & Vascular Research, Swedish Medical Center
Seattle, Washington, United States, 98122
United States, Wisconsin
Mesoblast Investigational Site 10764 - University of Wisconsin
Madison, Wisconsin, United States, 53792
Mesoblast Investigational Site 10769 - Aurora Healthcare
Milwaukee, Wisconsin, United States, 53215
Mesoblast Investigational Site 13279
Milwaukee, Wisconsin, United States
Mesoblast Investigational Site 10789 - Aspirus Research Institute
Wausau, Wisconsin, United States, 54401
Canada, Alberta
Mesoblast Investigational Site 11027
Edmonton, Alberta, Canada
Canada, British Columbia
Mesoblast Investigational Site 11024 - Victoria Heart Institute Foundation
Victoria, British Columbia, Canada, V8R 4R2
Canada, Ontario
Mesoblast Investigational Site 11025 - St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8
Sponsors and Collaborators
Mesoblast, Inc.
Investigators
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Study Chair: Donna Skerrett, MD Mesoblast, Ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mesoblast, Inc.
ClinicalTrials.gov Identifier: NCT02032004     History of Changes
Other Study ID Numbers: MSB-MPC-CHF001
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Mesoblast, Ltd. ( Mesoblast, Inc. ):
Chronic Heart Failure
CHF
Left Ventricular Systolic Dysfunction
Ischemic Heart Failure
Nonischemic Heart Failure
Stem Cells
Allogeneic Mesenchymal Precursor Cells
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases